FDA Adds Warning About Renal Risk to Trasylol Label

ROCKVILLE, Md., Dec. 15 -- The FDA announced today it had narrowed the indications for Trasylol (aprotinin injection), a drug used control bleeding during heart surgery, partly because of belatedly revealed risks of death or serious kidney damage.

The new label states that Trasylol should only be used in patients who have a high risk for increased blood loss and blood transfusion while on cardiopulmonary bypass pump during coronary artery bypass graft surgery.

The label will also include information about ways to manage and reduce patients' risk for hypersensitivity reactions.

In October the FDA chastised Bayer, the maker of the drug, for withholding data from a retrospective study that suggested the drug may increase the risk of death, serious kidney damage, congestive heart failure, and strokes.

At the time Bayer, which is headquartered in Leverkusen, Germany, admitted that it has knowingly withheld the damaging data from the FDA's Cardiovascular and Renal Drugs Advisory Committee, which reviewed Trasylol safety during a meeting on Sept. 21.

In response to the FDA's public criticism, Bayer posted an apology on its Web site and said it withheld the damaging data because it considered them preliminary.

The FDA initiated a safety review of Trasylol last January follow the publication of two studies.

One study reported an increase in the possibility of kidney failure, heart attack, and stroke in patients treated with Trasylol compared with those treated with other drugs.

The other study reported an increase in the possibility of kidney damage compared with other drugs, but did not show an increased risk of heart attack or stroke.

On Feb. 8, 2006, the FDA issued a Public Health Advisory regarding these new findings with Trasylol.